Table 1.
Patient demographics and baseline characteristics (FAS)
| Parameter | DA (comparative) (n = 131) | Roxadustat (comparative) (n = 131) |
|---|---|---|
| Sex, n (%) | ||
| Male | 75 (57.3) | 83 (63.4) |
| Female | 56 (42.7) | 48 (36.6) |
| Age, years | ||
| Mean (SD) | 70.9 (10.2) | 68.9 (11.6) |
| BMI, kg/m2 (prescreening) | ||
| Mean (SD) | 23.95 (3.57) | 23.58 (4.59) |
| Duration of anemia associated with CKD, months | ||
| Mean (SD) | 33.95 (45.94) | 28.39 (31.42) |
| Baseline Hb, g/dL | ||
| Mean (SD) | 10.96 (0.52) | 10.98 (0.57) |
| ERI, n (%) | ||
| <1.9 | 26 (19.8) | 32 (24.6) |
| ≥1.9–<3.5 | 40 (30.5) | 32 (24.6) |
| ≥3.5–<6.8 | 35 (26.7) | 30 (23.1) |
| ≥6.8 | 30 (22.9) | 36 (27.7) |
| Iron, µmol/L | ||
| Mean (SD) | 15.0 (5.0) | 16.0 (5.3) |
| Iron repletion, n (%) | ||
| Ferritin ≥100 ng/mL and TSAT ≥20% | 66 (50.4) | 69 (52.7) |
| Ferritin <100 ng/mL and TSAT ≥20% | 52 (39.7) | 51 (38.9) |
| Ferritin ≥100 ng/mL and TSAT <20% | 9 (6.9) | 6 (4.6) |
| Ferritin <100 ng/mL and TSAT <20% | 4 (3.1) | 5 (3.8) |
| Iron groups by repletion status, n (%) | ||
| Ferritin ≥100 ng/mL and TSAT ≥20% | 66 (50.4) | 69 (52.7) |
| Ferritin <100 ng/mL or TSAT <20% | 65 (49.6) | 62 (47.3) |
| Hs-CRP, nmol/L, n (%) | ||
| <28.57 | 106 (80.9) | 108 (82.4) |
| ≥28.57 | 25 (19.1) | 23 (17.6) |
| DM, n (%) | ||
| Present | 68 (51.9) | 68 (51.9) |
| Absent | 63 (48.1) | 63 (48.1) |
| eGFR, mL/min/1.73m2 (prescreening) | ||
| Mean (SD) | 18.2 (8.8) | 17.9 (8.2) |
| eGFR by mL/min/1.73m2 cutoff, n (%) | ||
| <15 | 62 (47.3) | 57 (43.5) |
| ≥15 | 69 (52.7) | 74 (56.5) |
| Primary disease of CKD, n (%) | ||
| CGN | 20 (15.3) | 33 (25.2) |
| DN | 52 (39.7) | 52 (39.7) |
| NS | 45 (34.4) | 36 (27.5) |
| Other | 14 (10.7) | 10 (7.6) |
| Concomitant ACEi/ARB use, n (%) | ||
| Yes | 109 (83.2) | 108 (82.4) |
| No | 22 (16.8) | 23 (17.6) |
| GNRI category, n (%) | ||
| <95.1 | 21 (16.0) | 31 (23.7) |
| ≥95.1–<98.3 | 25 (19.1) | 20 (15.3) |
| ≥98.3–<101.3 | 27 (20.6) | 18 (13.7) |
| ≥101.3–<104.2 | 24 (18.3) | 30 (22.9) |
| ≥104.2 | 34 (26.0) | 32 (24.4) |
| PNI category, n (%) | ||
| <43.6 | 30 (22.9) | 34 (26.0) |
| ≥43.6–<46.8 | 36 (27.5) | 29 (22.1) |
| ≥46.8–<49.7 | 37 (28.2) | 30 (22.9) |
| ≥49.7 | 28 (21.4) | 38 (29.0) |
ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; BMI, body mass index; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ERI, erythropoiesis-stimulating agent resistance index; FAS, full analysis set; GNRI, geriatric nutritional risk index; Hb, hemoglobin; PNI, prognostic nutritional index; SD, standard deviation; TSAT, transferrin saturation; DA, darbepoetin alfa; hs-CRP, high-sensitivity C-reactive protein; DM, diabetes mellitus; CGN, chronic glomerular nephritis; DN, diabetic nephropathy; NS, nephrosclerosis.